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Trial record 61 of 540 for:    IFNA2 AND RBV

Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

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ClinicalTrials.gov Identifier: NCT00686517
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : January 31, 2012
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Bioikos Ambiente Srl
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Biological: Pegylated interferon alfa-2b
Drug: Ribavirin
Enrollment 130
Recruitment Details  
Pre-assignment Details 130 participants were randomized to pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week for 24 weeks (PEG-IFN 24), pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week for 12 weeks (PEG-IFN 12), or pegylated-interferon alpha-2b at the dose of 1.5 mcg/kg/week + ribavirin at the dose of 10.6 mg/kg/day for 12 weeks (PEG-IFN + RVB 12).
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12
Hide Arm/Group Description Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
Period Title: Treatment
Started 44 43 43
Completed Final Treatment Visit 44 [1] 43 [2] 43 [3]
Completed 38 40 42
Not Completed 6 3 1
Reason Not Completed
Serious Adverse Event             1             2             1
Adverse Event             2             0             0
Poor Protocol Compliance             1             0             0
Protocol Violation             2             1             0
[1]
Included 6 that discontinued the treatment before completion,but performed the Final Treatment Visit
[2]
Included 3 that discontinued the treatment before completion,but performed the Final Treatment Visit
[3]
Included 1 that discontinued the treatment before completion,but performed the Final Treatment Visit
Period Title: Follow-up
Started 37 38 39
Completed 29 28 29
Not Completed 8 10 10
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12 Total
Hide Arm/Group Description Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 44 43 43 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 43 participants 43 participants 130 participants
36.55  (13.86) 38.32  (13.95) 38.52  (12.48) 37.79  (13.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 43 participants 43 participants 130 participants
Female
15
  34.1%
16
  37.2%
6
  14.0%
37
  28.5%
Male
29
  65.9%
27
  62.8%
37
  86.0%
93
  71.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 44 participants 43 participants 43 participants 130 participants
44 43 43 130
1.Primary Outcome
Title Number of Participants With Sustained Response (SR) at the End of the 6-month Follow-up Period
Hide Description SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
Time Frame Evaluated at the end of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12
Hide Arm/Group Description:
Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
Overall Number of Participants Analyzed 44 43 43
Measure Type: Number
Unit of Measure: participants
23 20 21
2.Secondary Outcome
Title Virologic Response at the End of Treatment Follow-up (ETR)
Hide Description

ETR was achieved if serum HCV RNA level at the end of 12 or 24 weeks

treatment (depending on treatment arm) was <15 IU/mL.

Time Frame At the end of treatment (either 12 weeks or 24 weeks depending on randomization).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12
Hide Arm/Group Description:
Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
Overall Number of Participants Analyzed 44 43 43
Measure Type: Number
Unit of Measure: participants
26 28 27
3.Secondary Outcome
Title Virologic Response at 12 Months Post-treatment Follow-up (Long-term Response, [LTR]).
Hide Description LTR was obtained if serum HCV RNA level at the end of 12-month follow-up was <15 IU/mL.
Time Frame At 12 months post-treatment (treatment period either 12 weeks or 24 weeks depending on randomization).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12
Hide Arm/Group Description:
Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
Overall Number of Participants Analyzed 44 43 43
Measure Type: Number
Unit of Measure: participants
20 19 19
4.Secondary Outcome
Title Number of Participants Presenting With Alanine Transferase (ALT) Level Normalization
Hide Description ALT normalization was used as a measure of biochemical response to treatment. ALT levels were assessed at each study visit by the local laboratory, and efficacy measurements at the end of treatment, at 6 and 12 months post treatment follow-up were reported.
Time Frame Evaluated at end of treatment (either 12 weeks or 24 weeks, depending on randomization), at 6-month follow-up visit, or at 12-month follow-up visit.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12
Hide Arm/Group Description:
Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
Overall Number of Participants Analyzed 44 43 43
Measure Type: Number
Unit of Measure: participants
End of Treatment 28 31 32
6-month Follow-up Period 31 27 28
12-month Follow-up Period 27 23 23
5.Secondary Outcome
Title Number of Participants With Rapid Virologic Response (RVR)
Hide Description

Participants were considered to have RVR if serum HCV RNA level at 2 or 4

weeks of treatment was below the cut off value of the referring local

laboratory of each participating site.

Time Frame Evaluated at 2 and 4 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT): including all randomized participants who received at least one dose of study medication. Participants without measurements at the end of treatment or who discontinued the study for any reason before the end of the treatment were considered as non-responders.
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12
Hide Arm/Group Description:
Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
Overall Number of Participants Analyzed 44 43 43
Measure Type: Number
Unit of Measure: participants
2 weeks after start of treatment 24 25 23
4 weeks after start of treatment 28 35 34
6.Secondary Outcome
Title Number of Peripheral Blood Mononuclear Cells (PBMCs)
Hide Description Cellular Differentiation Cluster Antigen 8-Positive (CD8+) PBMCs were measured at randomization, Treatment Weeks 2, 4, 8, and 12.
Time Frame Treatment Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
The association between HCV specific immune and SR to be assessed applying descriptive methods could not be evaluated as PBMC measurements were not carried out.
Arm/Group Title PEG-IFN 24 PEG-IFN 12 PEG-IFN + RVB 12
Hide Arm/Group Description:
Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks
Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PEG-IFN 12 PEG-IFN 24 PEG-IFN + RVB 12
Hide Arm/Group Description Pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks Pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks Pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin 10.6 mg/kg/day for 12 weeks
All-Cause Mortality
PEG-IFN 12 PEG-IFN 24 PEG-IFN + RVB 12
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN 12 PEG-IFN 24 PEG-IFN + RVB 12
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/43 (6.98%)      4/44 (9.09%)      4/43 (9.30%)    
Ear and labyrinth disorders       
HypoAcusis  1/43 (2.33%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Endocrine disorders       
Autoimmune thyroiditis  0/43 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Gastrointestinal disorders       
Diarrhea  0/43 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Vomiting  0/43 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Infections and infestations       
Dacryocystitis  0/43 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Wound Infection  0/43 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
Investigations       
Transaminases Increased  1/43 (2.33%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung Neoplasm Malignant  0/43 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Nervous system disorders       
Headache  1/43 (2.33%)  1 0/44 (0.00%)  0 0/43 (0.00%)  0
Optic Neuritis  0/43 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Psychiatric disorders       
Mania  0/43 (0.00%)  0 0/44 (0.00%)  0 1/43 (2.33%)  1
Pyschotic Disorder  0/43 (0.00%)  0 1/44 (2.27%)  1 0/43 (0.00%)  0
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN 12 PEG-IFN 24 PEG-IFN + RVB 12
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/43 (86.05%)      43/44 (97.73%)      42/43 (97.67%)    
Blood and lymphatic system disorders       
Anemia  0/43 (0.00%)  0 1/44 (2.27%)  1 4/43 (9.30%)  4
Granulocytopenia  22/43 (51.16%)  25 32/44 (72.73%)  44 26/43 (60.47%)  34
Leukopenia  31/43 (72.09%)  36 30/44 (68.18%)  45 31/43 (72.09%)  37
Neutropenia  6/43 (13.95%)  7 3/44 (6.82%)  3 2/43 (4.65%)  2
Gastrointestinal disorders       
Abdominal Pain  0/43 (0.00%)  0 4/44 (9.09%)  4 2/43 (4.65%)  2
Abdominal Pain Upper  0/43 (0.00%)  0 1/44 (2.27%)  1 3/43 (6.98%)  3
Constipation  0/43 (0.00%)  0 3/44 (6.82%)  3 0/43 (0.00%)  0
Dyspepsia  4/43 (9.30%)  4 0/44 (0.00%)  0 3/43 (6.98%)  3
Nausea  2/43 (4.65%)  2 7/44 (15.91%)  9 3/43 (6.98%)  4
General disorders       
Asthenia  12/43 (27.91%)  12 11/44 (25.00%)  11 7/43 (16.28%)  7
Chills  4/43 (9.30%)  4 1/44 (2.27%)  1 6/43 (13.95%)  6
Irritability  2/43 (4.65%)  2 4/44 (9.09%)  4 2/43 (4.65%)  2
Pain  8/43 (18.60%)  8 9/44 (20.45%)  9 7/43 (16.28%)  8
Pyrexia  27/43 (62.79%)  31 30/44 (68.18%)  35 28/43 (65.12%)  34
Investigations       
Hemoglobin Decreased  1/43 (2.33%)  1 7/44 (15.91%)  7 5/43 (11.63%)  5
Platelet Count Decreased  7/43 (16.28%)  7 5/44 (11.36%)  6 1/43 (2.33%)  1
Transaminases Increased  4/43 (9.30%)  4 8/44 (18.18%)  9 2/43 (4.65%)  2
Weight Decreased  0/43 (0.00%)  0 4/44 (9.09%)  4 1/43 (2.33%)  1
Metabolism and nutrition disorders       
Decreased Appetite  1/43 (2.33%)  1 7/44 (15.91%)  7 1/43 (2.33%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  11/43 (25.58%)  15 13/44 (29.55%)  14 13/43 (30.23%)  13
Myalgia  1/43 (2.33%)  1 3/44 (6.82%)  3 4/43 (9.30%)  4
Nervous system disorders       
Headache  11/43 (25.58%)  11 13/44 (29.55%)  15 12/43 (27.91%)  14
Psychiatric disorders       
Anxiety  1/43 (2.33%)  1 2/44 (4.55%)  2 3/43 (6.98%)  3
Depression  2/43 (4.65%)  2 6/44 (13.64%)  6 5/43 (11.63%)  6
Insomia  1/43 (2.33%)  1 5/44 (11.36%)  5 3/43 (6.98%)  3
Skin and subcutaneous tissue disorders       
Alopecia  4/43 (9.30%)  4 7/44 (15.91%)  7 2/43 (4.65%)  2
Erythrema  0/43 (0.00%)  0 3/44 (6.82%)  4 3/43 (6.98%)  3
Pruritus  1/43 (2.33%)  1 1/44 (2.27%)  1 4/43 (9.30%)  6
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigator agrees not to publish or publish or present any results of the study without the prior written permission of Schering-Plough The principal investigator further agrees to allow the Sponsor to review, 30 days prior to submission for publication or presentation, copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686517     History of Changes
Other Study ID Numbers: P03552
First Submitted: May 27, 2008
First Posted: May 30, 2008
Results First Submitted: December 22, 2011
Results First Posted: January 31, 2012
Last Update Posted: April 5, 2017